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Developed in cooperation with: 

MedBoard and Regulatory Globe invested over 1000 hours to develop and optimize this IVDR vs IVDD Gap-Assessment Tool. The integrated correlation table between IVDD and IVDR will help to get a much deeper understanding of the upcoming changes and helps to reduce requirements much faster. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Visual correlation between IVDD and IVDR
• Wording Gap-Analysis between IVDD and IVDR
• Free corrigendum updates until May 2022
• Significant saving of working hours
• Unique keyword search function
• Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

Our Payment Partners:

The post IVDD vs IVDR Gap-Assessment Tool first appeared on Regulatory Globe.

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We invested over 1000 hours to develop and optimize this IVDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the IVDR impacts on your QMS immediately. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Reference table to ISO 13485:2016
• Including a Gap-Report
• Including a Project-Plan
• Free corrigendum updates until May 2022
• Significant saving of working hours
• Unique keyword search function
• Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

Our Payment Partners:

The post IVDR Gap-Assessment Tool incl. ISO 13485:2016 first appeared on Regulatory Globe.

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Recommended by: 

In the last 3 years, we invested over 600 hours to develop and optimize our IVDR Gap-Assessment Tool to have one of the best tools in the medical device space. Download our test version today to get a first impression of how it works, and how powerful this tool can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Free corrigendum updates until May 2022
• Significant saving of working hours
• Very simple to use
• Unique keyword search function
• Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

How it works:

[video width="1280" height="720" mp4="https://www.regulatoryglobe.com/wp-content/uploads/2019/05/MDR-IVDR-Tool-how-does-it-work.mp4"][/video]

Our Payment Partners:

The post IVDR Gap-Assessment Tool first appeared on Regulatory Globe.

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Our Payment Partners:

The post MDR vs IVDR Comparison Table first appeared on Regulatory Globe.